Translational Recording and Characterization of Epilepsy Signals Using Subgaleal EEG During Standard-of-care SEEG Monitoring

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Adraxe Corp.
Study ID
NCT07821697
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Epilepsy (Treatment Refractory)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EEG Record only — DEVICE
    Subgaleal EEG recording

Study Details

TRACE is a record-only study evaluating subgaleal EEG (sgEEG) recorded concurrently with standard-of-care stereoelectroencephalography (SEEG) in adults with drug-resistant epilepsy undergoing inpatient epilepsy monitoring. The study will assess the ability of sgEEG to detect seizures and characterize seizure timing, signal quality and stability, and lateralization compared with SEEG.

Key Dates

First listed
Sep 16, 2026
Start date
Oct 15, 2026
Status verified
Sep 2026
Primary completion
Oct 15, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Single arm
    Record only

Primary Outcome Measure

Event-Level Seizure Detection by Subgaleal EEG Compared With SEEG [ Time Frame: During concurrent sgEEG and standard-of-care SEEG monitoring, up to 14 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnisotaMinneapolisMinnesota55414
Lindsey Study Coordinator
[email protected]
8582498702

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By research site
University of Minnisota· Minneapolis, MN

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